2023-10-25-世界卫生组织-INN_Recommended_List_90_198页_7mb

Summary of the Document

Core Content

The document provides a list of Recommended International Nonproprietary Names (INNs) for pharmaceutical substances, specifically List 90. These names are selected by the World Health Organization (WHO) to standardize the naming of drug substances, ensuring consistency and clarity in global pharmaceutical communication. The names are presented in Latin, English, French, and Spanish, with associated chemical names, molecular formulas, and graphic formulas. It is important to note that the inclusion of a name in the INN list does not imply any recommendation for its medical use.

Main Views

• INN Selection Process: The names are selected in accordance with the WHO's Procedure for the Selection of Recommended INNs, which includes specific guidelines for naming.
• Language Support: The names are provided in four languages: Latin, English, French, and Spanish, facilitating international use.
• No Medical Recommendation: The document emphasizes that the inclusion of a name in the INN list does not indicate any recommendation for medical use.
• Comprehensive Lists: It references the Cumulative List No. 17, 2017, which contains both proposed and recommended INNs, available only in CD-ROM format.

Key Information

1. Acimtamigum / Acimtamig / Acimtamig

• Description: A bispecific, tetravalent monoclonal antibody with specific targeting of FCGR3A (CD16a) and TNFRSF8 (CD30).
• Origin: Produced in Chinese hamster ovary (CHO) cells, specifically the CHO-DG44 cell line.
• Glycoform: Glycoform alfa.
• Structure: Composed of Homo sapiens and Mus musculus VH-V-kappa-VH'-V-lambda chains.
• Post-translational Modifications:
  • Disulfide bridges: Intra-chain and inter-chain locations are specified.
  • N-terminal glutaminyl cyclization: Indicates pyroglutamyl modification.
  • O-glycosylation: Residues are listed with uncertainty about their precise location.
  • N-glycosylation: Specific sites are indicated, with a note that the glycosylation is complex and fucosylated.

2. Aderamastatum / Aderamastat

• Chemical Structure: A complex molecule with multiple sulfur and oxygen atoms.
• Molecular Formula: $\mathrm{C} _ {2 8} \mathrm{H} _ {3 2} \mathrm{N} _ {2} \mathrm{O} _ {6} \mathrm{S} _ {4}$.
• Structure Description: A bispecific, tetravalent molecule with heavy and light chains.
• Post-translational Modifications:
  • Disulfide bridges: Locations are detailed.
  • N-terminal modification: Pyroglutamyl.
  • N-glycosylation: Specific sites are noted.
  • C-terminal modification: Lysine clipping.

3. Alsecovateinum / Alsecovateine / Alsecovateina

• Description: A trimeric form of the SARS-CoV-2 spike glycoprotein, in a stable prefusion conformation.
• Variants: Includes mutations R669>Q, R670>Q, R672>Q, K973>P, V974>P.
• Production: Synthesized in insect cells (Sf9).
• Glycoform: Glycoform alfa.
• Post-translational Modifications:
  • Disulfide bridges: Multiple intra-chain and inter-chain locations.
  • N-glycosylation: Multiple sites are listed.
  • O-glycosylation: Experimentally confirmed, but with uncertainty about specific residues.

4. Andusomeranum / Andusomeran

• Description: mRNA encoding a pre-fusion stabilised variant of the SARS-CoV-2 spike glycoprotein.
• Omicron Variant: Based on XBB.1.5, using data from GISAID: EPI_ISL_15948646.
• Structure: Contains stop codons, an artificial 5’ UTR, a 3’ UTR derived from human alpha globin gene (HBA1), and an IDR sequence.
• Post-translational Modifications:
  • Modified Nucleosides: Contains N’-methylpseudouridine instead of uridine.
  • Vector Components: Includes ψ packaging signal, cPPT sequence, and WPRE.
  • Pseudotyping: Vector is pseudotyped with VSV G glycoprotein.
  • Glycosylation: None reported.

5. Anitocabtagenum autoleucelum / Anitocabtagene autoleucel

• Description: Autologous T lymphocytes transduced with a lentiviral vector expressing a chimeric antigen receptor (CAR) targeting BCMA.
• CAR Structure: Includes a three-helix bundle D domain, CD8α hinge and transmembrane domain, and 4-1BB and CD3ζ signaling domains.
• Expression: Controlled by the EF1α promoter.
• Production Process:
  • Leukapheresis: T lymphocytes are obtained from peripheral blood mononuclear cells.
  • Immunoselection: Enriched for CD4+ and CD8+ T cells.
  • Activation: With CD3 and CD28 agonists.
  • Expansion: In growth media containing IL-2 and human AB serum.
• Function: Demonstrates cytotoxicity against BCMA-expressing cells and secretes IFN-γ and IL-2.

6. Anpocoginum / Anpocogin / Anpocogina

• Description: Anticoagulant protein c2 from Ancyclostoma canium.
• Modification: A C-terminal P85 addition.
• Production: Synthesized in Pichia pastoris.
• Sequence: Provided in the document.
• Post-translational Modifications:
  • Disulfide bridges: Locations are specified.
  • Glycosylation: None reported.

Conclusion

The document serves as a comprehensive resource for Recommended International Nonproprietary Names (INNs) and related pharmaceutical substances. It highlights the standardization of drug names, the multilingual approach to ensure global accessibility, and the importance of post-translational modifications in the structure and function of these molecules. Each entry includes detailed chemical and structural information, mutations, and production details, making it a valuable reference for pharmaceutical research and development.